Panel Urges New Vaccine For Newborns

February 22, 2006|By Justin Gillis The Washington Post

WASHINGTON — Every healthy newborn in the United States should receive a new vaccine designed to protect against an intestinal germ called rotavirus, a federal advisory panel decided Tuesday as it set aside theoretical concerns about the vaccine's safety.

The decision means that pediatricians are likely to recommend three doses of the vaccine for nearly every child at age 2 months, 4 months and 6 months, beginning almost immediately. The oral vaccine won approval from the Food and Drug Administration on Feb. 3 and some doctors have received supplies of it.

The recommendation for universal use of the vaccine was approved at a meeting of the Advisory Committee on Immunization Practices, the federal panel that sets vaccination policy in the United States. It comes nearly seven years after an earlier rotavirus vaccine was withdrawn from the market for causing a potentially life-threatening form of intestinal blockage in some babies.

Vaccine-safety advocates are urging parents to be wary of the new vaccine because of that history. The federal Centers for Disease Control and Prevention and the manufacturer, Merck & Co. Inc. of Whitehouse Station, N.J., have promised elaborate studies to catch any safety problems. Merck is selling the vaccine under the brand name RotaTeq.

Merck has tested the vaccine on about 70,000 babies in 11 countries, one of the biggest vaccine trials ever conducted. That test ruled out a safety problem similar to the one that felled RotaShield, an earlier rotavirus vaccine developed by Wyeth, a drugmaker in Madison, N.J. But doctors said it is impossible to design a test big enough to catch all possible side effects.

RotaTeq is expected to be one of the most expensive vaccines ever marketed, with Merck listing it at $187.50 wholesale for the three-dose series. That means many doctors are likely to charge more than $300 retail, putting the Merck product in league with Prevnar, an expensive Wyeth vaccine that has been widely used in the United States for five years.

RotaShield appeared on the market in late 1998 but was pulled less than a year later after a handful of babies who had received it developed a serious intestinal problem called intussusception, a type of bowel obstruction.